AN OVERVIEW OF PHARMACEUTICAL AND

AGROCHEMICAL DATA PROTECTION

Brazilian and Latin American Cases

Gabriel Di Blasi

DATA PROTECTION

CONCEPT AND GENERAL ASPECTS

Data Protection ≠ Data Exclusivity

�Provides protection of undisclosed test data

generated by clinical trials and submitted to

regulatory authorities.

�Legally and economically necessary for the drug

development process.

�Prevents regulatory authorities and third parties

from inadequately using data submitted by

innovative companies .

CONDITIONS FOR DATA PROTECTION.

� Data submission to the regulatory authorities is a

pre-requisite for marketing approval.

� The generation of the data has to involve a

considerable effort.

� The drug should be a new chemical entity.

� The value of the data is related to its secrecy.

DATA PROTECTION

TRIPS

� Article 39.3

� Protection against disclosure.- Exception: to protect the public. ( MANDATORY SHARING OF THE

DATA UPON ADEQUATE COMPENSATION)

� Protection against unfair commercial use.

DATA PROTECTION

TRIPS

� Some options for the members to use the correct

implementation of article 39.3

a. Exclusivity time limit for the use of data

b. Cost-sharing or other mechanism to provide

adequate compensation

PROTECTION OF DATA PROTECTION

� TRIPs-plus agreements- Flexibilities to the TRIPS

agreement.

� Stronger protection for submitted data.

� Patent Term extension.

� Linkage between patent protection and

product registered number (Orange book).

� Restrictions on patent nullity.

� Incentive to Innovation

DATA PROTECTION IN BRAZIL

HUMAN BEING VETERINARIAN AND

AGROCHEMICAL

DATA PROTECTION IN BRAZIL

� For human being use:

Main aspects - (XIV art. 195, 9.279/96 )

� Requirements for protection;

� Granted rights;

� Unfair competition considered as a crime;

� No exclusivity time limit for the use of data;

� No administrative procedure to prevent the

disclosure of data;

� Civil Tort – losses and damages;

� Disclosure by regulatory authority for public health.

PHARMACEUTICAL REGISTRATION

Types of Pharmaceutical Products Registration

Law No. 6.360/76

Reference Generic Similar or

(Me Too)

DATA PROTECTION IN BRAZIL Brazilian Courts Understanding

In favor

� The Brazilian Regulatory Authority (ANVISA) has to

demand that the tests required in the legislation are

performed

� Regardless of the kind of drug, to which registration is

granted, it must have its safety and efficacy

scientifically proved:

Against

� The authorization for the marketing of generic and

similar drugs disclaims the submission of the tests

required for the reference drugs

DATA PROTECTION Y IN BRAZIL

� For veterinary and agrochemical use:

Main aspects - Law 10.603/02

� Originated by the Provisional Act 69/02.

� Protection of undisclosed information only concerns

veterinarian and agrochemical products.

� Establishes an exclusivity period for data confidentiality of

drugs for animal use and agrochemicals.

� Compulsory use may be granted, in case of misuse by the

originator.

PATENT LINKAGE

• Brazilian case:

– No patent linkage: The procedure for the

market approval does not require any

information from BPO regarding Intellectual

Property Rights of the pharmaceutical product.

– Law 10.603/2002, art 13.

– Industrial Property Law, article 43, VII.

DATA PROTECTION IN LATIN AMERICA

� The Andean Pact – Bolivia, Ecuador, Peru,

Colombia and Venezuela (Art. 266, decision

486/00)

� Treaty of Group of 3 – Colombia, Mexico and

Venezuela (Arts. 18-22 , Treaty)

� FTAs in Latin America:

� Period of protection: 5 years at least

� New pharmaceutical products

� Prevent Similar products

� Protection of undisclosed information

DATA PROTECTION IN LATIN AMERICA

COUNTRIES WITH DATA

EXCLUSIVITY PERIOD

COUNTRIES WITHOUT DATA

EXCLUSIVITY PERIOD

5- years

Bolivia (Andean Pact, art. 266/decision 486)

Ecuador (Andean Pact, art. 266/ 486 )

Mexico (NAFTA)

Peru (Andean Pact, art. 266/decision 486 and FTA )

Guatemala (Art 177, Decree nº 30/05 and CAFTA-

human being)

3 to 5-years

Colombia (Andean Pact, art. 266/decision 486 and

FTA)

5 to 10-years

Brazil (veterinary and agrochemical) (**)

Panama (Law No. 23; Section 7) (**)

10-years

Guatemala (Art 177, Decree nº 30/05 and CAFTA -

veterinary and agrochemical)

Argentina (*) (**)

Brazil (human being) (*) (**)

Chile (FTA) (*) (**)

Costa Rica (CAFTA) (*) (**)

Paraguay

Trinidad & Tobago

The Dominican Republic (*)

Uruguay

El Salvador (CAFTA) (*)

Nicaragua (CAFTA) (*) (**)

Honduras (CAFTA) (*) (**)

Venezuela (*) (**)

(*) Priority Watch List Countries –USTR

(**) No Patent Linkage or Deficient Patent linkage system

Pharmaceutical Research And Manufacturers of America (PhRMA)

special 301 submission 2010

International Federation of Pharmaceutical Manufactures

&Associations – IFPMA

CONCLUSION

� Strong patent and data protection for pharmaceuticals as a benefit for innovation.

� In Brazil there is peculiar legal treatment to human being pharmaceutical use in comparison to agrochemical and veterinarian use;

� Brazilian Courts decisions related to the drug registration are not final and conclusive yet;

� Data protection and Patent linkage can be regarded as two of the hottest and controversial issues for the developing countries, especially for Latin America.

Thank you!

Gabriel Di Blasi

gabriel.diblasi@diblasi.com.br

Di Blasi, Parente, Vaz e Dias & Associados

Rua do Ouvidor, 121, 11th floor

Rio de Janeiro – RJ - Brazil

T +55 (0)21 3981 0080

F +55 (0)21 3981 0090